RecruitingPhase 1Phase 2NCT06708663

HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours

Phase IIa Study of HX009+IN10018 in Patients With Advanced Solid Tumours, Including Biliary Tract Malignancies and Malignant Melanoma, Treated With or Without Standard Chemotherapy

Sponsor

Hangzhou Hanx Biopharmaceuticals, Ltd.

Enrollment

124 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer Melanoma

Summary

Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — HX009 (a dual PD-1 and CD47 antibody) and IN10018 (a FAK inhibitor) — with or without standard chemotherapy, in people with advanced solid tumors including bile duct cancers and melanoma that have not responded to prior treatments. **You may be eligible if...** - You are between 18 and 70 years old - You have advanced or metastatic solid tumor cancer confirmed by biopsy - Your life expectancy is at least 12 weeks - You are in good physical condition (ECOG 0-1) - For Phase 1: your cancer has failed standard therapy or there is no effective standard treatment - For Phase 2: you have not received prior systemic therapy (or finished adjuvant/neoadjuvant therapy at least 6 months ago) **You may NOT be eligible if...** - Your cancer type is excluded by the protocol - You are pregnant or breastfeeding - You have other conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHX009+IN10018

The 7.5 mg/kg dose group will first enroll 3 to 6 subjects, and if the 7.5 mg/kg dose group is tolerable, then 3 to 6 subjects will continue to be enrolled into the 10 mg/kg dose group; if the 7.5 mg/kg dose group is not tolerable, a decision will be made to add a new, lower dose group after discussion between the sponsor and the investigator; in addition, based on the available study data, the sponsor and the investigator will discuss and decide whether to add an unplanned dose group or an exploratory group and decide on the appropriate recommended dose (RP2D) for the Phase IIa study. IN10018 is fixed dose at 100mg daily.